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510(k) K000637

Device
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
Applicant
ALCON LABORATORIES, INC.
510(k) number
K000637
Product code
NCF  
Decision
Se - With Limitations (SESU)
Decision date
2000-05-19
Date received
2000-02-25
Regulation
886.1760
Classification name
Aberrometer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
S.K. MCGARVEY
Address
2800 Discovery Dr., Orlando FL US 32826 32826

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062930LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMAlcon Research, Ltd.2006-11-08
K050336OPD-STATION SOFTWARENidek, Inc.2005-08-24
K023249ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMAlcon Laboratories, Inc.2002-10-18

Legacy Summary#

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FDA Review#

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